Effects of Foot Reflexology on Severity of Pain and Opioid Dosage Administered to Patients Undergoing a Discectomy: A Randomized Clinical Trial

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Effects of Foot Reflexology on Severity of Pain and Opioid Dosage Administered to Patients Undergoing a Discectomy: A Randomized Clinical Trial
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    Open Access                                                                                                      Original Article
                                  Crescent Journal of Medical and Biological Sciences
                                  Vol. 8, No. 3, July 2021, 209–214
                                  eISSN 2148-9696

Effects of Foot Reflexology on Severity of Pain and Opioid
Dosage Administered to Patients Undergoing a Discectomy:
A Randomized Clinical Trial
                                 ID                                   ID
Mehdi Khanbabayi Gol1 , Davoud Aghamohamadi2*

    Abstract
    Objectives: The present study aimed to investigate the effects of foot reflexology on the severity of pain and opioid dosage
    administered to patients undergoing a discectomy.
    Materials and Methods: The present randomized clinical trial (concurrent parallel) was conducted including two experimental
    groups. In general, 60 patients were selected from Imam Reza and Shohada hospitals of Tabriz based on convenience sampling
    and then randomly assigned to the intervention (n=30) and control (n=30) groups based on randomly permuted blocks. Four hours
    after the surgery and the last dosage of pethidine, patients in the intervention group received massaging of both feet 20 minutes per
    day for 2 days while those in the control group received no intervention. The data were collected using a demographics and visual
    analogue scale (VAS) checklist and then were statistically analyzed using chi-square, Fisher exact test, and the independent t-test
    in SPSS-21 at the 0.05 level of significance.
    Results: After the intervention, the severity of pain significantly reduced in the intervention group (P < 0.001) but it did not change in
    the control group (P > 0.410). The results indicated no significant difference between the two groups in pre-intervention pethidine
    dosage (P > 0.490). After the intervention, pethidine dosage significantly decreased in the intervention group on all days (P < 0.001),
    but no significant change was observed in the control group (P > 0.499).
    Conclusions: Considering the positive effects of foot reflexology on the severity of pain and reduced dosage of the required opioids
    for pain control, this technique is recommended to be used as a perfect complementary therapy, along with other treatments to
    reduce postoperative pain in patients undergoing a discectomy.
    Keywords: Foot reflexology, Discectomy, Severity of pain, Opioids

Introduction                                                                less used for patients undergoing surgery on their spinal
Surgeries on the spinal column are considered among                         cord (4,5). On the other hand, some studies have reported
the most painful medical procedures. Due to extensive                       that foot reflexology cannot properly reduce postoperative
neurological damages in such surgeries, postoperative                       pain (6,7). Regarding the complications of opioid drugs
pain control is quite important to both physicians and                      and the fear of using these drugs, the use of non-
patients. Improper pain control in such patients can lead                   prescriptive methods is necessary for reducing pain after
to undesirable outcomes (1).                                                a discectomy. In addition, there are a few studies about
  Supplementary therapies such as massage act as                            the effects of foot reflexology on the severity of pain after
a supportive intervention for improving all painful                         a discectomy and surgeries of the spinal cord. Therefore,
experiences during hospitalization. Reflexology or foot                     the present study mainly aimed to evaluate the effects of
massage is a natural and old treatment. Reflexologists                      foot reflexology on the severity of pain and opioid dosage
believe that all body organs and glands are connected to                    administered to patients undergoing a discectomy.
reflex areas on the feet, hands, and ears (2). They claim
that they can reduce tensions, improve blood circulation                    Materials and Methods
and normal functioning of related areas, and finally,                       The current randomized clinical trial (concurrent parallel,
reduce pain in the corresponding body parts by applying                     double-blind) included two experimental groups in order
pressure to the feet and hands with specific thumb, finger,                 to determine the effects of foot reflexology on the severity
and hand techniques without the use of oil or lotion (3).                   of pain and opioid dosage administered to patients
Although the desirable results of foot reflexology have                     undergoing a discectomy. The inclusion criteria were a
been observed in some surgeries, this technique has been                    minimum literacy level of writing and reading, lack of

Received 10 January 2019, Accepted 16 June 2019, Available online 23 August 2019
1
 Responsible for the Nursing Research Committee of Imam Reza Hospital, Nursing and Midwifery Faculty, Tabriz University of Medical
Sciences, Tabriz, Iran. 2Department of Anesthesiology, School of Medicine, Imam Reza Medical, Tabriz University of Medical Sciences
*Corresponding Author: Davoud Aghamohamadi, Email: dr.daghamohammadi@yahoo.com
Khanbabayi Gol and Aghamohamadi

Key Messages                                                                     participants were admitted to the brain surgery ward, their
                                                                                 severity of pain was measured and recorded using the VAS
 ►► The pain after discectomy is very severe.
 ►► Attempt to control pain after discectomy is non-
                                                                                 checklist and those with a score of 3 or more were selected
    pharmacological.                                                             for the study. Then, foot reflexology was performed by a
 ►► Foot reflexology led to the control of pain after discectomy.                skilled physiotherapist for 20 minutes for each patient in
                                                                                 a separate room. First, the physiotherapist attempted to
                                                                                 establish a friendly relationship with patients by taking
                                                                                 their medical history and then asked them to comfortably
having a surgical procedure other than a discectomy, no                          lie down in a prostrate position. Before starting the
history of foot reflexology, no history of taking sedatives,                     massage, the physiotherapist washed his/her hands with
analgesics, or anxiolytics such as Inderal (propranolol)                         lukewarm water and dipped them into a baby oil with no
for more than a month, non-addiction to drugs, non-                              healing value, and then cleaned the patients’ feet with a
affliction with known diseases such as cardiovascular                            wet towel. The foot massage consisted of 20 actions in
diseases, diabetes, visual impairment, and hearing loss,                         3 steps. First, the right foot was massaged with the first
the health of feet, and a score of 3 or more on the visual                       6 actions that generally lasted 1.5 minutes (each action
analogue scale (VAS) checklist. On the other hand, the                           lasted 15 seconds). The right foot was covered with a towel
exclusion criteria included preoperative complications                           and the same actions were performed on the left foot for
such as severe bleeding or acute infection, the need for                         1.5 minutes. After covering the left foot, the second 6
admission to the intensive care unit, and lack of complete                       actions were performed on both feet for 1.5 minutes. The
consciousness during the intervention. In addition, other                        third step included 8 actions that were simultaneously
exclusion criteria were unpleasant feelings and complaints                       performed on both feet in 7 minutes. In this step, the
during the intervention, an unwillingness to continue                            first two actions were performed in 1 minute and each of
the study, the need for taking painkillers more than the                         the next actions lasted for 1 minute. Specialized massage
routine, and the arbitrary use of painkillers by patients.                       exercises including rubbing, rotating, stretching, gripping,
   The study population consisted of patients undergoing                         and bending were performed on different parts of the
a discectomy who were willing to participate in the study.                       foot from the ankle to toes for 20 minutes (10 minutes
The participants were selected based on convenience                              for each foot) once a day for 2 consecutive days (12). The
sampling from patients meeting the inclusion criteria in                         first massage exercise was performed at 5-9 pm at least 4
Imam Reza and Shohada hospitals of Tabriz. The sample                            hours after the surgery and the second one was performed
size was determined based on a sample size formula                               24 hours later at the same time. In the control group, the
considering a confidence level of 95% and a test power of                        physiotherapist was present at the patients’ bedside and
80% (8). As a result, 30 patients undergoing a discectomy                        attempted to establish a friendly relationship with patients
were selected from each hospital (15 patients for the                            by taking their medical history in order to determine the
intervention group and 15 patients for the control group).                       pure effect of massage on pain reductions by controlling
Considering an attrition rate of 20%, a total of 60 patients                     the effect of the masseur’s presence. Thirty minutes
were selected from the 2 hospitals for the study (8). The                        after the 2 sessions of intervention, the assistant author
participants were assigned to intervention and control                           measured and recorded the patients’ severity of pain
groups based on randomly permuted blocks.                                        using the VAS checklist. All patients received analgesics
   The required data were collected using a demographics                         according to the routines of the studied hospitals and
form and the VAS checklist. Demographic characteristics                          there was no difference between the 2 groups in this
included age, gender, occupation, educational attainment,                        regard. The pethidine dosage administered to patients
marital status, number of children, anesthetic status,                           was recorded 11 hours before and after the intervention.
number of postoperative suppositories, height, weight,                           It is noteworthy that the author, the data analyzer, and the
body mass index (BMI), and the pethidine dosage                                  physician were unaware of grouping and intervention.
consumed within 48 hours after the surgery. VAS is                                  Ethical considerations were fully observed like
a visual scale as a horizontal ruler graded from 0 to 10                         other studies (13-15). All patients were briefed on the
that measures the severity of pain. On this ruler, 0 and                         research objectives and procedure and were assured of
10 denote no pain and very severe pain, respectively (9).                        discontinuing the study at any stage. Then, an informed
Based on Cronbach’s alpha, the reliability of this scale was                     written consent form was obtained from all patients. In
obtained 0.89-0.91 (10). Its reliability and validity have                       addition, necessary arrangements were made with the
been also confirmed in Iran (11).                                                authorities and matrons of the studied hospitals.
   The demographic information of participants was
recorded by an assistant researcher who was unaware of                           Statistical Analyses
participants’ assignment to experimental groups. The                             Chi-square test and Fisher exact test were used to
participants were trained for using the VAS checklist                            compare the intervention and control groups in terms
before the surgery. After the surgery and when the                               of demographics. In addition, the independent t-test was

210    Crescent Journal of Medical and Biological Sciences, Vol. 8, No. 3, July 2021
Khanbabayi Gol and Aghamohamadi

employed to compare the two groups regarding the pre-                          (Table 2), the severity of pain significantly reduced in
and post-intervention mean score of pain. All statistical                      patients in the intervention group on all days of the study
analyses were performed in SPSS 21 at the 0.05 level of                        (P < 0.001) while it changed significantly in the control
significance.                                                                  group in none of the study days (P > 0.410).
                                                                                 The results further demonstrated that there was no
Results                                                                        significant difference between the intervention and control
In total, 80 patients were identified for the study while                      groups in terms of the mean pethidine dosage before the
excluding 20 cases due to the lack of entry criteria. After                    intervention (P > 0.490). However, a significant difference
random allocation to control and intervention groups,                          was found between the two groups in this regard after the
30 patients received the intervention, none of who were                        intervention (P < 0.001). The results of the independent
eliminated during the intervention, and statistical analysis                   t test (Table 3) also revealed that the pethidine dosage
was performed for every 30 people )Figure 1).                                  administered to patients in the intervention group was
   The mean age and the mean BMI of patients were                              significantly lower than that of the control group on all
58.50 ± 8.20 and 29.80 ± 3.2250, respectively. The majority                    days (P < 0.001).
of patients (n = 48, 80%) were males, half of them (n = 30,
50%) had a high school diploma, 71.66% (n = 43) of them                        Discussion
were clerks, 71.66% (n = 43) of them were married, and                         The present study aimed to investigate the effects of foot
all of them (n = 60, 100%) were under general anesthesia.                      reflexology on the severity of pain and opioid dosage
Table 1 presents the results of the chi-square test and the                    administered to patients undergoing a discectomy.
independent t-test for comparing the intervention and                          Researchers believe that massage therapy and reflexology
control groups in terms of demographics.                                       are simple and learnable treatments that can be applied
   The results of the independent t-test showed that there                     to a wide range of clinical problems. Because of its
was no significant difference between the intervention and                     simple and easy nature, reflexology can increase patients’
control groups in terms of the pre-intervention severity                       involvement in self-care (16). On the other hand, studies
of pain on the first, second, and third days (P > 0.419).                      have shown that reflexology can reduce anxiety, improve
However, there was a significant difference between                            the components of life quality and sleep quality, and relax
the two groups in severity of pain after the intervention                      the patient by reducing the severity of pain (17). In the
(P < 0.001). Based on the results of the independent t test                    present study, foot reflexology managed to reduce the

                     Enrollment                               Assessed for eligibility (n=80)

                                                                                           Excluded (n= 20)
                                                                                            Not meeting inclusion criteria (n=20)

                                                                    Randomized (n=60)

                                                                   Allocation
               Allocated to intervention (n=30)                                        Allocated to intervention (n=30)
                Received allocated intervention (n=30)                                 Received allocated intervention (n=30)

                                                                     Follow-Up
                Lost to follow-up (n=0)                                               Lost to follow-up (n=0)

                Discontinued intervention (n=0)                                       Discontinued intervention (n=0)

                                                                     Analysis
               Analysed (n=30)                                                         Analysed (n=30)

                                     Figure 1. The Flow Chart of the Recruitment and Retention of Participants.

                                                           Crescent Journal of Medical and Biological Sciences, Vol. 8, No. 3, July 2021    211
Khanbabayi Gol and Aghamohamadi

Table 1. Comparison of Patients in the Intervention and Control Groups in Terms of Demographics

                                                           Intervention                                           Control
 Variables                                                                                                                                    P Value
                                              Mean±SD              Max            Min            Mean±SD              Max    Min

 Age (year)                                  59.75±8.45             70             45           60.25±8.50            77     46               0.495

 Weight (kg)                                85.90±12.20             92             75          87.20±11.30            90     69               0.505

  Height (cm)                               169.50±15.45           186            157          163.50±14.59           182    153              0.611

 BMI (kg/m )  2
                                             31.15±3.10           22.30            35           29.15±3.15            25     36.1             0.399

                                                                         Occupation (n, %)
 Housewife                                                    9-30%                                              8-26.66%
                                                                                                                                               0.7
 Clerk                                                       21-70%                                              22-73.34%
                                                                 Educational attainment (n, %)
 Less than high school                                        5-70%                                                7-70%
 High school                                                 16-70%                                               14-70%
                                                                                                                                              0.523
 University degree                                            9-70%                                                9-70%
                                                                   Number of children (n, %)
 0-2                                                       28-93.33%                                             26-86.66%
                                                                                                                                               0.7
 2-4                                                        2-06.64%                                             4-13.34%

                                                                    Anesthesia status (n, %)

 General anesthesia                                         30-100%                                               30-100%                       1

Table 2. Comparison of Patients in the Intervention and Control Groups in Terms of Severity of Pain

 Day                                                               Intervention (Mean±SD)             Control( Mean±SD)             P Value
                                 Before the intervention                   04.75±0.33                      04.82±0.60                0.565
 First                           After the intervention                     2.88±0.15                      04.78±0.55
Khanbabayi Gol and Aghamohamadi

that reflexology had positive effects on the reduction of            affect the results. Compared to other studies conducted in
pain and proper management of postoperative pain (8).                this area, one of the strengths of the present study was the
In another study conducted by Lalehgani et al, it was                presence of the physiotherapist, along with the patients in
shown that foot reflexology had positive and beneficial              the control group in order to determine the pure effect
effects on post-discectomy pain management. They also                of massage on pain reductions by controlling the effect
concluded that this technique can be widely used as a                of the masseur’s presence. Other strengths of this study
complementary therapy in patients undergoing surgery                 included the homogeneity of the study groups in terms of
on the spinal cord (1). The results of the above-mentioned           gender, type of surgery, type of anesthesia, and analgesics
studies are consistent with the findings of the present              dosage administered to patients, random assignment of
study in terms of the positive effects of foot reflexology           participants to the intervention and control groups, and
on postoperative pain management. Other studies about                unawareness of the assistant researcher about grouping
the effects of reflexology on patients undergoing heart              and interventions.
surgery (18), thoracic surgery (19), and cesarean section
(20) also reported similar results. Eghbali et al evaluated          Suggestions for Future Studies
the effects of foot reflexology on the severity of low back          Based on the study findings, future studies are
pain in nurses and showed that reflexology had positive              recommended to investigate the long-term effects of foot
effects on reducing low back pain (21). Another finding              reflexology and its impact on chronic pains.
of the present study demonstrated that foot reflexology
dramatically reduced the opioids dosage administered                 Authors’ Contribution
                                                                     MKG: Study design, intervention; DA: Intervention, submission,
to patients. Consistent with the results of this study,              article writing.
Stephenson et al reported a significant reduction in the
opioids dosage administered to patients following foot               Conflict of Interests
reflexology (17).                                                    Authors have no conflict of interests.
  In the present study, foot reflexology had short-term
                                                                     Ethical Issues
effects on the reduction of postoperative pain, and it
                                                                     The research project was approved by the Ethics Committee of
again increased on the day after reflexology. Keller et al           Tabriz University of Medical Sciences (ethics no. IR.TBZMED.
investigated the effects of 8 weeks of massage therapy on            REC.1397.1059) and registered at the Iranian Registry of Clinical
the severity of pain after a discectomy and concluded that           Trials website (identifier: IRCT20120605009948N6; https://www.
this technique had short-term effects on pain reductions             irct.ir/trial/38485).
and patients’ severity of pain increased after one week
                                                                     Financial Support
(22).                                                                This study was granted by Tabriz University of Medical Sciences.

Conclusions                                                          Acknowledgments
Considering the study findings and the further reduction             The present paper presents part of the research project approved
of pain severity in the intervention group compared with             by the Clinical Research Development Unit of Tabriz University of
                                                                     Medical Sciences. The researchers would like to give their gratitude
the control group, foot reflexology can be used as a perfect
                                                                     to the Research Center and the Health Vice-chancellor of Tabriz
complementary therapy, along with other treatments                   University of Medical Sciences for financial support in the study..
to reduce postoperative pain in patients undergoing
discectomy. Based on the findings, a reduction was found             References
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